BEUDAMED
    FDA Recall Terminated

    Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

    Recall: Z-0837-2009 · Initiated October 9, 2008

    Recall

    Recall Number
    Z-0837-2009
    Event Number
    50140
    Firm
    Boston Scientific Corporation
    FEI Number
    2939204
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 9, 2008
    Posted
    January 28, 2009
    Terminated
    July 27, 2009
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    Description

    Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

    Reason

    Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.

    Action

    Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.

    Distribution

    Worldwide Distribution --- USA including Puerto Rico and country of Panama

    Quantity

    1033 units